A foreign manufacturer and sponsor of a US clinical study (IDE) has currently no product commercialized in the United-States, therefore, has no US Agent.
I will use the term of US Sponsor although this does not seem to be an official word and is not defined by regulations.
As part of the IDE, the FDA requested to have a US Sponsor assigned. In 21 CFR Part 812, the only information about US sponsor is in part 812.18 related to the import of the investigational device. "In addition to complying with other requirements of this part, a person who imports or offers for importation an investigational device subject to this part shall be the agent of the foreign exporter with respect to investigations of the device and shall
act as the sponsor of the clinical investigation, or ensure that another person acts as the agent of the foreign exporter and the sponsor of the investigation."
In the regulations, there is never any mention of IDE US Sponsor aside from what has been quoted above. My question is twofolds;
1) In terms of importing the investigational device in the United-States, does every shipment need to come directly to the "agent" of the foreign sponsor or can it be shipped directly to the investigators?
2) What does "act as the sponsor" mean? On the FDA website, there is also the following information posted:
Can a foreign company submit an IDE/Is a U.S. Sponsor required?
A foreign company cannot sponsor an IDE; they must have a U.S. agent who acts as the sponsor (see 21 CFR 812.18(a)). The U.S. agent must fulfill all the responsibilities of a sponsor identified in the IDE regulation.
So if we go back to 21 CFR part 812. subpart C which describes all the responsibilities of the Sponsor, does that mean that the US Sponsor of the foreign Sponsor has the SAME responsibilities: for monitoring, maintaining records etc...as the "real" Sponsor of the study who is actually based overseas? This designated US Sponsor / Agent who acts for the foreign sponsor: which records must they have, can the FDA audit them, must they keep records of the agreements with the CRO, the investigators, CRFs and all clinical records that a Sponsor would have etc....???
By the way, that foreign Sponsor has recently been FDA audited at their foreign facility, a BIMO audit which went very well because they had all the records at their foreign facility.
It is unclear to me the role of that US Sponsor for a foreign IDE sponsor and how far it goes. The role of US agent after commercialization is well defined and very limited.
I first thought that the role of US Sponsor would be similar, but the FDA has told me that no, it has ALL the responsibilities of the Sponsor, without subsequently addressing my "materialistic" questions.
Can anyone share with me your experience? Your ideas? Your interpretations and why?
Thank you very much,
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Catherine Gloster RAC
Gloster Biomedical International
Santa Barbara CA
United States
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